Incorporating Patient Preferences in the Development of Novel Kidney Replacement Therapy

Workgroup

Sheldon, Murray – Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland
Tarver, Michelle E. – Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland
Neuland, Carolyn – Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland
Chaudhuri, Shomesh E. – QLS Advisors, LLC, Cambridge, Massachusetts
Lo, Andrew W. – Sloan School of Management, Massachusetts Institute of Technology, Cambridge, Massachusetts; Laboratory for Financial Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts; Computer Science and Artificial Intelligence Laboratory, Massachusetts Institute of Technology, Cambridge, Massachusetts; Department of Electrical Engineering and Computer Science, Massachusetts Institute of Technology, Cambridge, Massachusetts; Santa Fe Institute, Santa Fe, New Mexico
Flythe, Jennifer E. – Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina School of Medicine, University of North Carolina Kidney Center, Chapel Hill, North Carolina; Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, North Carolina
West, Melissa – Kidney Health Initiative and American Society of Nephrology, Washington, DC
Conway, Paul T. – American Association of Kidney Patients
Knight, Richard – American Association of Kidney Patients
Forfang, Derek – Kidney Health Initiative Patient and Family Partnership Council, San Pablo, California
Harris, Raymond C – Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, Tennessee
Wood, Dallas – RTI Health Solutions, Research Triangle Park, North Carolina
Hurst, Frank P.– Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland
Tarver, Michelle E. – Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland

Incorporating Patient Preferences in the Development of Novel Kidney Replacement Therapy

Projects

Portfolio:

Devices

Barrier Type:

Patient Preferences

There is uncertainty regarding the approval of advanced medical devices, accessories, software, and mobile medical applications for consumer use. Reimbursement policies vary significantly across Medicaid, Medicare, and commercial insurance. This regulatory and payer misalignment and the knowledge gap is hindering patient access to technologies and services that have potential to improve outcomes for patients on home based therapies.

KHI assembled a workgroup tasked with addressing the state of remote monitoring wireless health/telemedicine technology that can be utilized to treat patients with kidney disease and assessing potential clinical and economic value. This information will be used to address key regulatory, legal, legislative, and reimbursement barriers affecting the adoption and usage of such technologies. The workgroup developed a manuscript and presented their findings at a workshop.